Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT03905057
Eligibility Criteria:
Inclusion Criteria:
* Men scheduled for robotic bilateral nerve-sparing radical prostatectomy
* Diagnosed with low/intermediate-risk prostate cancer:
* PSA \< 20 ng/ml
* Gleason score \< 8
* PCa stage =\< T2b
* Baseline IIEF-ED 22-30 without erectogenic aids
* No urinary incontinence (no usage of urinary pads)
* Sexually active, in a stable heterosexual relationship
* Able to understand and complete patient questionnaires
* Consent to participate
Exclusion Criteria:
* Anatomical abnormalities in the genitalia or pelvic region
* Post-RP complications that could impact safety or effectiveness of ESWT (eg. hematoma, fistula, unresolved anastomotic leak)
* Incomplete tumor removal (positive surgical margin)
* Tumor upstaging beyond T2b
* Nerve sparing score \< 4
* Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy
* Untreated hypogonadism (serum total testosterone \< 300 mg/dL)
* Anti-coagulant medication, or any blood coagulation disorders (INR \> 3)
* Any other condition that would prevent the patient from completing the study, as judged by the principle investigator
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
65 Years
Study:
NCT03905057
Study Brief:
Protocol Section:
NCT03905057